The European framework for intellectual property rights for biological medicines

Introduction: The Pharmaceutical Strategy for Europe (2020) proposes actions related to intellectual property (IP) rights as a means of ensuring patients’ access to medicines. This review aims to describe and discuss the European IP framework and its impact on accessibility of biological medicines and makes some recommendations. Methods: A non-systematic literature review on IP for biological medicines was conducted. Data on authorizations and patent and exclusivity expiry dates of biological medicines obtained from the European Medicines Agency’s (EMA) website and literature was analysed quantitatively and qualitatively. Results: The analysis showed that as at end July 2021, 1,238 medicines were authorized in Europe, of which 332 (26.8%) were biological medicines. There were only 55 biosimilars for 17 unique biologicals. There is an increasing trend in biological authorizations but signifi cant delays in submission of applications for marketing authorization of biosimilars, with no signifi cant diff erences in the time for assessment for marketing authorization between originator biologicals and biosimilars. For some of the more recent biosimilars, applications for authorization were submitted prior to patent and exclusivity expiry. COVID vaccines confi rmed the impact of knowledge transfer on accessibility, especially when linked to joint procurement. Discussion: IP protects originator products and impacts the development of biosimilars. Strategies to improve competition in the EU biological market are discussed. Pricing policies alone do not increase biosimilar uptake since patients are switched to second generation products. Evergreening strategies might be abusing the IP framework, and together with trade secrets and disproportionate prices compared to R & D and manufacturing costs lead to an imbalance between market access and innovation. Conclusion: The European Pharmaceutical Strategy should focus on IP initiatives that support earlier authorization of biosimilars of new biologicals. Recommendations include knowledge sharing, simplifi cation of the regulatory framework and transparency of prices and R & D costs.

EU on the way toward Health Union

The article deals with numerous initiatives of the EU Commission, both legislative and political, aimed at strengthening the MS coordination in the field of health. Based on the Commission’s recommendations on restrictions of freedom of movement, the author analyzes the «colour coding» of the EU regions to discover travelers arriving from «risk zones», and identifies conflicting approaches of Member States and other critics to this practice. The author shows interest in Commission’s activities for joint procurement of coronavirus vaccines and other medicines and medical instruments, which it carries out using the power received from the Member States. However, the author notes that only a few MS take advantage of these contracts, preferring their national procurement channels. The author considers Commission’s desire to take the next steps in the direction of the Health Union a significant event in the EU health policy. In conclusion, the author foresees upcoming discussions about who will make decisions in the field of health policy in the EU.

The Role of the Joint Procurement Agreement during the COVID-19 Pandemic: Assessing Its Usefulness and Discussing Its Potential to Support a European Health Union

In 2014, the European Joint Procurement Agreement (JPA) was introduced as an innovative instrument to organise the procurement of vaccines and medications in preparation for pandemics. An overriding purpose of the JPA is to secure equitable and cost-effective access to medical supplies for participating EU Member States during serious health crises. This article aims to understand the current use of the JPA in response to the COVID-19 pandemic. Post-analysis of the recent use of the JPA, the article will discuss how the regional procurement mechanism can be strengthened to support the development of a European Health Union. In particular, the article will firstly question whether the four recent JPA procurement actions facilitated equitable access to medical supplies and services. Secondly, it will ask whether the centralised procurement actions preserved the integrity of the Internal Market. The importance and originality of this study are that it addresses an instrument, the JPA, which has been largely overlooked by legal scholars, and it explores how the provisions for the joint procurement of medical countermeasures as included in Article 5 of Decision 1082/2013/EU on serious cross-border threats to health could be extended to support the functioning of a European Health Union.

The importance of health security in post-Brexit EU–UK relations

This article examines the possibilities for negotiating the UK–EU health-security relationship after 2020. Health security, in the sense of measures to prevent and mitigate health emergencies, had played a marginal role in the UK–EU negotiations, but COVID-19 has greatly amplified this policy area’s significance. At the beginning of the pandemic, Brussels introduced significant measures to promote public health sovereignty, notably joint procurement and stockpiling of personal protective equipment. The UK went against the grain by limiting its involvement in joint procurement at a time when other countries were rushing to participate. UK participation in some EU health measures is possible on existing terms, but not joint procurement. This leaves the UK facing an uncertain future because of the potential risks associated with not participating in EU programmes, notably in terms of access to personal protective equipment supplies and possible market distortion resulting from new EU policies promoting stockpiling and reshoring. The politicisation of health security thus adds another complication to the post-Brexit EU–UK relationship.